Could a common vitamin lift depression in young people?

NCT ID NCT07793071

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

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First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

Researchers at Massachusetts General Hospital are testing whether daily oral thiamine, also known as vitamin B1, can reduce depression symptoms in children and adolescents aged 8 to 17.5 with major depressive disorder. Participants take a 100 mg thiamine capsule daily for 4 weeks and attend weekly virtual visits to track mood, safety, and side effects. Blood samples are collected before and after the study to measure thiamine levels. The trial aims to see if this simple vitamin supplement offers a safe and effective way to help manage youth depression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral thiamine hydrochloride (vitamin B1)
What this could lead to
If thiamine works, it could offer a simple, low-cost, and well-tolerated option to help manage depression in young people, possibly as an add-on to standard care.
What could go wrong
This is a small, early-phase, open-label trial, so results may not hold up in larger, blinded studies. Thiamine is generally safe, but it may not improve depression for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female participants aged 8 to 17.5 years (inclusive) at the time of enrollment * Diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) * Evidence of clinically significant symptoms of depression as indicated by a T score\> 60 on the Children's Depression Inventory 2 (CDI-2) parent form at prescreening * Evidence of clinically significant symptoms of depression in the mild to moderate range as indicated by a score between 40 and 70 on the Children's Depression Rating Scale--Revised (CDRS-R) at screening * Subjects and their caregivers must be English-speaking and have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. * Subject and their caregiver must be willing and able to comply with all study procedures. * Each subject and his/her authorized parent/guardian must understand the nature of the study. The subject's authorized parent/guardian must sign an informed consent document, and the subject must sign an informed assent document. * Subject must be able to swallow pills. * Subject must have access to a computer with a camera, speaker, microphone, and internet connection. * Subjects must be willing to refrain from treatment changes during the study protocol. Exclusion Criteria: * Recent history or active clinically significant manifestations of infectious, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, neurological, endocrinological or eyes, ears, nose, and throat disorders, or any other acute or chronic condition that, in the Investigator's opinion, would limit the participant's ability to complete or participate in this clinical study. * History of sensitivity to thiamine * Severe allergies or multiple adverse drug reactions. * History of nutritional deficiencies other than thiamine deficiency that could interfere with the study protocol or confound results. * DSM-V diagnosis of substance use disorder, abuse or dependence. * Judged clinically to be at serious suicidal risk for Columbia-Suicide Severity Rating Scale (C-SSRS) score ≥4. * Severe symptoms of depression as indicated by CDRS-R score \>70. * Current diagnosis of bipolar disorder. * Current diagnosis of schizophrenia. * Current diagnosis or symptoms of psychosis. * Previous or current diagnosis of Intellectual Disability. * Participants who are on stable pharmacotherapy will be included as long as the medication has been stable for at least 6 weeks prior to screening and will continue without change for the duration of the study. Participants on pharmacotherapy that has not been stable for at least 6 weeks will be excluded. * Participants who are in stable psychotherapy will be included as long as they have started psychotherapy at least 3 months prior to screening and will continue therapy without change for the duration of the study. Participants receiving psychotherapy that has not been stable for at least 6 weeks will be excluded. * Concomitant treatment or treatment within the last month with neuroleptics, antipsychotics, anticonvulsants, sedatives or hypnotics. * More than two antidepressant treatment failures at an adequate dose and duration (at least 6 weeks) in the current major depressive episode. * Having started psychotherapy (including cognitive behavioral therapy \[CBT\]) less than 3 months prior to Screening * Pregnancy: Female participants who are pregnant or breastfeeding will be excluded to avoid risks to the child and ensure safety in the use of thiamine.

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Conditions

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